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Menopause Live - IMS Updates

Date of release: 18 April, 2011

Vaginal pH-balanced gel for the control of atrophic vaginitis in breast cancer survivors

Introduction

A recently published randomized, controlled trial [1] has examined the effects of a topical vaginal pH-balanced gel on symptoms of atrophic vaginitis amongst women who have been treated for breast cancer. Ninety-eight women were enrolled in the study and 86 completed the trial. All participants were postmenopausal prior to the diagnosis of their breast cancer. The hypothesis tested was whether the topical application of a lactic acid gel with a pH of 4.0 would improve vaginal symptoms, including dyspareunia, and objective measures of vaginal health. The active gel, or an identical placebo, was self-administered three times a week for a 12-week treatment period. Women treated with the low pH gel experienced significant reduction in vaginal dryness and dyspareunia compared with women treated with placebo. Three-weekly use of the low pH gel also resulted in a reduction in vaginal pH and a significant improvement in the vaginal maturation index. Although a significant proportion of the women in the study experienced vulvovaginal irritation with the treatment, few women discontinued the study.

This study therefore demonstrates that the lowering of vaginal pH in postmenopausal women improves vaginal health and reduces symptoms of vaginal atrophy and hence offers an alternate therapeutic approach for women experiencing vaginal atrophy after treatment for breast cancer.

Comment

The majority of breast cancers diagnosed are hormone receptor-positive such that most women will be treated with endocrine therapy, resulting in estrogen deprivation. As a consequence, vaginal atrophy is a common and chronic problem for women treated for breast cancer. Primarily presenting as vaginal dryness and dyspareunia, vaginal atrophy has substantial impact on sexual well-being. Recent research has shown that in the vicinity of 70% of women experience sexual function problems 2 years after diagnosis of breast cancer [2]. Women using aromatase inhibitors are more likely to experience sexual function problems than women not on any endocrine therapy [2]. The usual treatment approach is the recommendation of lubricants and vaginal moisturizers and, in some instances, the prescription of vaginal estrogen therapy. This study demonstrates that a low pH vaginal gel used three times a week reduces vaginal symptoms in association with objective measures of improved vaginal health. This presents yet another option for the management of women experiencing vaginal atrophy in association with breast cancer therapy. Although application of the gel was associated with some degree of vaginal irritation and burning, this was self-limited, as evidenced by a high study completion rate.

An interesting aside from the primary outcome is that participants in this study were required to be menopausal prior to the diagnosis of their breast cancer, yet the average age of the study participants was only 45 years. Rather than this being interpreted as a young age of menopause in the South Korean population, this more likely reflects younger postmenopausal women with breast cancer being more troubled by dyspareunia and sexual difficulties. Management of dyspareunia is only one component of dealing with the whole spectrum of sexual problems encountered by women receiving treatment for breast cancer. Counselling may be useful for women experiencing body image concerns. However, treatments to address loss of libido secondary to hormonal deprivation are lacking. It is most unfortunate that therapeutic options such as flibanserin have not been studied in this population.

Comentario

Susan DavisDirector, the Womens Health Research Program, School of Public Health and Preventive Medicine, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia